Valve system for inflatable devices

ABSTRACT

Valves and valve systems are provided that are useful for integration with inflatable indwelling medical devices to prevent over-inflation of retention balloon.

CROSS-REFERENCE

This application is a U.S. National Phase of International ApplicationNo. PCT/US2016/059132, filed on Oct. 27, 2016, which claims the benefitof U.S. Provisional Application No. 62/247,934 filed on Oct. 29, 2015,which is incorporated herein by reference in its entirety.

BACKGROUND OF THE INVENTION

Indwelling medical devices are a common and indispensable part ofmedical care. Indwelling devices may be placed within a bodily organ orpassage to promote drainage of fluid matter from the body, for example,via a catheter. Indwelling medical devices may have an inflatableportion such as a retention balloon for retaining and/or sealing thecatheter within the body. Proper inflation is used for retaining thecatheter within the body and deflated for insertion into and removalfrom the body, without harming the patient.

Indwelling medical devices are used in fecal management systems (FMS) toenable the temporary diversion and containment of waste fluids inpatients who are often bed-ridden, immobilized, and/or fecalincontinent. FMS can protect wounds from fecal contamination, reduce therisk of skin breakdown, reduce the spread of infection, and provide asafe and effective alternative to traditional methods of fecalincontinence such as pads, diapers, and fecal pouches.

SUMMARY OF THE INVENTION

Fecal incontinence is a common condition affecting patients in intensivecare units and places a heavy burden on hospital personnel and carriessignificant risks to patients. Complicated and harmful effects includeskin breakdown and the development of pressure ulcers, as well as thespread of C. difficile, an infectious bacterium that can be found indiarrhea.

In fecal management systems, a retention balloon is located at thedistal end of a catheter. The retention balloon may be inserted into thebody in a deflated condition and positioned inside the rectal cavity.Once properly positioned, the retention balloon may be inflated via aninflation port which may be located on a distal end of a tube thatprovides a passageway to the retention balloon and extends along thecatheter on the outside of the body. It is important that the retentionballoon is not over-inflated and does not exceed pre-determinedpressures. The present disclosure provides valves and valve systems forthe prevention of over-inflation of inflatable indwelling medicaldevices, including fecal management systems. Additional indwellingmedical devices include catheter balloon dilatations which are widelyused to dilate areas of narrowing in blood vessels, ureters, and in thegastrointestinal tract, such as urinary catheters, airway catheters,tracheal catheters, drainage devices, patency devices, devices for theadministration of therapeutics and drugs, feeding tubes, and the like.

In one aspect, provided herein is an apparatus for limiting fluidpressure within an inflatable portion of an inflatable device, whereinthe inflatable device comprises a supply fluid path and a return fluidpath individually connecting the inflatable portion to the apparatus,the apparatus comprising: a body comprising a fluid inlet port and afluid outlet port connected by a first passage, wherein the firstpassage is connected to the supply fluid path at the fluid outlet port;a second passage connected to the return fluid path, wherein the firstpassage and the second passage are not in fluid communication within theapparatus; and wherein a pressure relief valve is located such that whenthe fluid pressure in the inflatable portion and the second passageexceeds a predetermined pressure, the pressure relief valve opens andexcess fluid is released from the inflatable portion. In someembodiments, the first passage of the apparatus is not obstructed whenthe pressure within the inflatable portion exceeds the predeterminedpressure, such that the apparatus is configured to allow for theinflatable portion to receive fluid via the first passage when thepressure within the inflatable portion exceeds the predeterminedpressure. In some embodiments, the predetermined pressure is thecracking pressure of the pressure relief valve. In some embodiments, thepredetermined pressure is from about 30 mm Hg to about 90 mm Hg, or fromabout 50 mm Hg to about 70 mm Hg. In some embodiments, the pressurerelief valve comprises an umbrella valve, spring loaded ball valve,spring loaded poppet valve, rupturing disk, or a combination thereof. Insome embodiments, the pressure relief valve has a height no greater thanabout 20, 15, 10, 9, 8, 7, 6 or 5 mm. In some embodiments, the pressurerelief valve is positioned within the second passage. In someembodiments, the apparatus further comprises a fill indicator located atthe second passage of the apparatus. In some embodiments, the pressurerelief valve is not ferromagnetic. In some embodiments, the fillindicator is a pressure indicator comprising a mechanical elementconfigured to alternate between a first physical state and a secondphysical state when a pressure within the inflatable portion meets orexceeds an optimal fill pressure. In some embodiments, the optimal fillpressure is from about 10 mm Hg to about 60 mm Hg. Further providedherein is the inflatable medical device. In some embodiments, theinflatable portion of the inflatable medical device has a maximum fillvolume, at which point the pressure within the inflatable portion is thepredetermined pressure. In some embodiments, the maximum fill volume isfrom about 35 ml to about 50 ml. In some embodiments, the maximum fillvolume is about 50 ml±5 ml.

In another aspect, provided herein is an inflatable indwelling medicaldevice comprising: (a) an apparatus comprising a fluid inlet port and afluid outlet port connected by a first passage, and a second passage;wherein the first passage and the second passage are not connectedwithin the apparatus; and (b) a retention balloon; wherein a supplyfluid path connects the first passage of the apparatus at the fluidoutlet port to the retention balloon, and a return fluid path connectsthe second passage of the apparatus to the retention balloon; whereinthe second passage comprises a pressure relief valve that opens torelieve pressure within the retention balloon when the pressure withinthe retention balloon reaches a predetermined pressure. In someembodiments, the predetermined pressure is from about 30 mm Hg to about90 mm Hg, or from about 50 mm Hg to about 70 mm Hg. In some embodiments,the apparatus further comprises a fill indicator that providesnotification when the retention balloon is filled to or above an optimalfill pressure, the fill indicator positioned within the second passage.In some embodiments, the optimal fill pressure is from about 30 mm Hg toabout 60 mm Hg. In some embodiments, the pressure relief valve comprisesan umbrella valve, spring loaded ball valve, spring loaded poppet valve,rupturing disk, or a combination thereof. In some embodiments, theretention balloon is positioned at the distal end of a catheter forinsertion into a body cavity of a patient, and the proximal end of thecatheter is configured for coupling to a collection bag.

In another aspect, provided herein is a method of filling an inflatableportion of a device to a predetermined operating range, the methodcomprising: (a) providing the device comprising the inflatable portion,the inflatable portion being in fluid communication with (i) aninflation port via a first passage, and (ii) a fill indicator and apressure relief valve in a closed configuration, via a second passage;wherein the inflatable portion has a minimum operating fill volume and amaximum operating fill volume, and a fill volume between and includingthe minimum and maximum operating fill volumes is the predeterminedoperating range of the inflatable portion; and wherein the first passageand the second passage are enclosed within an apparatus, and the firstpassage and the second passage are not in fluid communication within theapparatus; (b) providing a fluid to the inflatable portion through theinflation port and the first passage to fill the inflatable portionuntil the fill indicator indicates that the minimum operating fillvolume is achieved; and (c) optionally continuing to provide the fluidto the inflation portion through the inflation port and the first fluidpassage until: (i) the pressure relief valve opens into an openconfiguration to restrict the inflation portion from being filled beyondthe maximum operating fill volume, or ii) before the pressure reliefvalve opens into the open configuration. In some embodiments, thepressure relief valve opens at a cracking pressure from about 30 mm Hgto about 90 mm Hg, or from about 50 mm Hg to about 70 mm Hg. In someembodiments, the inflatable portion is inserted into a cavity of asubject. In some embodiments, the pre-determined operating range of theinflatable portion is determined by the identity and/or dimensions ofthe cavity of the subject. In some embodiments, the method comprisesselecting a cracking pressure of the pressure relief valve depending onthe cavity of the subject. In some embodiments, the minimum operatingfill volume is from about 30 ml to about 45 ml, or from about 35 ml toabout 45 ml. In some embodiments, the maximum operating fill volume isfrom about 45 ml to about 70 ml, or from about 45 ml to about 55 ml. Insome embodiments, the pressure relief valve is positioned on a valveseat, and wherein a cracking pressure of the pressure relief valve isdependent on the height of the valve seat. In some embodiments, thepressure relief valve comprises an umbrella valve, spring loaded ballvalve, spring loaded poppet valve, rupturing disk, or a combinationthereof. In some embodiments, the pressure relief valve has a height nogreater than about 20, 15, 10, 9, 8, 7, 6 or 5 mm. In some embodiments,the fill indicator is a pressure indicator comprising a mechanicalelement configured to alternate between a first physical state and asecond physical state when a pressure within the inflatable portionmeets or exceeds minimum operating fill volume.

INCORPORATION BY REFERENCE

All publications, patents, and patent applications mentioned in thisspecification are herein incorporated by reference to the same extent asif each individual publication, patent, or patent application wasspecifically and individually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an embodiment of an inflatable indwelling medical devicecomprising a retention balloon and a valve system B for preventingover-inflation of the retention balloon.

FIG. 2A is an embodiment of a valve system B comprising an umbrellavalve.

FIG. 2B is an embodiment of an umbrella valve for use in a valve systemprovided herein.

FIG. 3A is an embodiment of a valve system B comprising a spring loadedball valve.

FIG. 3B is an embodiment of a spring loaded ball valve for use in avalve system provided herein.

FIG. 4A is an embodiment of a valve system B comprising a spring loadedpoppet valve.

FIG. 4B is an embodiment of a spring loaded poppet valve for use in avalve system provided herein.

FIG. 5 is an embodiment of a rupturing disc for use in a valve systemprovided herein.

FIG. 6 is a plot of balloon diameter versus the inflated volume of theballoon when the balloon is inflated with air in a system having or nothaving a pressure relief valve.

FIG. 7 is a plot of balloon pressure versus the inflated volume of theballoon when the balloon is inflated with air in a system having or nothaving a pressure relief valve.

FIG. 8 is a plot of balloon diameter versus the inflated volume of theballoon when the balloon is inflated with water in a system having ornot having a pressure relief valve.

FIG. 9 is a plot of balloon pressure versus the inflated volume of theballoon when the balloon is inflated with water in a system having ornot having a pressure relief valve.

FIG. 10 is a plot of balloon pressure versus the inflated volume of theballoon when the balloon is inflated with water in systems having or nothaving a pressure relief valve. One system comprised a pressure reliefvalve having a 60 mm Hg cracking pressure, and another system compriseda pressure relief valve having a 75 mm Hg cracking pressure.

DETAILED DESCRIPTION OF THE INVENTION

In fecal management systems, a distally placed retention balloon may beinserted into the body in a deflated condition and positioned inside therectal cavity. It is important that the retention balloon is notover-inflated and does not exceed pre-determined pressures in thepatient. Complications of over-inflation include bruising, ulceration,tissue necrosis and infection in the patient. Challenges for controllingand maintaining proper and adequate pressure in the retention ballooninclude a limited footprint in the medical devices to incorporatepressure relief and maintenance systems, including safety concerns forpatients, adequate pressure control and prevention of pressure spikes ifincorporated into the inlet or inflation lumen of the retention balloon,and the low pressure maintained in the retention balloon, presenting atechnical challenge in maintaining pressures in the range of 10 mm Hg to100 mm Hg (approximately 0.2 psi to 2 psi).

The present invention provides valves and valve systems, includingpressure relief valves, for the prevention of over-inflation ofinflatable indwelling medical devices, including fecal managementsystems. In some embodiments, the pressure relief valve is incorporatedinto the outlet or returning lumen of the retention balloon system inorder to address the challenges presented in low pressure maintenanceand control. In addition, the pressure relief valves described hereinmay be mechanical, with a small footprint or dimension, allowingoperation within the low pressure maintenance systems used in theseindwelling medical devices. Additional indwelling medical devicesinclude catheter balloon dilatations which are widely used to dilateareas of narrowing in blood vessels, ureters, and in thegastrointestinal tract, such as urinary catheters, airway catheters,tracheal catheters, drainage devices, patency devices, devices for theadministration of therapeutics and drugs, feeding tubes, and the like.

Referring to FIG. 1, an embodiment of an inflatable indwelling medicaldevice A is shown comprising a valve system B and an elongated flexibletubular element 102 having a distal end 104 for positioning the device Ainto a body cavity of a patient. The proximal end 106 of tubular element102 may connect to a receptacle to collect waste from the patient thatdrains through an interior of the tubular element 102 when the device Ais positioned within the patient. Affixed to the exterior surface of thedistal end 104 of the tubular element 102 is an inflatable retentionballoon 108, shown in its inflated state, that serves to anchor thedistal end 104 of the device A in the body cavity.

Retention balloon 108 is connected to a valve system B through a supplyfluid path provided by a supply lumen 110 and return fluid path providedby a return lumen 122. Valve system B is designed for limiting fluidpressure within the retention balloon 108 during inflation and when theretention balloon 108 is held within the body cavity. The body 112 ofvalve system B comprises an inlet port 116 for receiving a connectorassociated with a source of fluid for inflation of the retention balloon108, and an outlet port 114 connected to the supply fluid path, theinlet port 116 and outlet port 114 connected via a first passage withinbody 112.

Valve system B further comprises a second passage connected to thereturn fluid path, the second passage comprising a fill indicator 118and pressure relief valve 120. The second passage is connected to theretention balloon 108 via the return fluid path such that the secondpassage receives the pressure from retention balloon 108. If thepressure within the retention balloon 108 exceeds a first pressure, forexample, during inflation, the fill indicator 118 provides anotification, such as a visual and/or audible notification, to thepractitioner filling the retention balloon 108 to remove excess fluidfrom the retention balloon 108 via the inflation port 116. If thepressure within the retention balloon 108 exceeds a second pressure, thepressure relief valve 120 will open, releasing excess fluid from theretention balloon 108 through the second passage of the valve system.The second pressure may be the same or greater than the first pressure.In some cases, the first pressure is an optimal pressure of theretention balloon 108, so that the fill indicator 118 notifies apractitioner filling the retention balloon 108 that the optimal pressurehas been met and to halt inflation. If the fill indicator 118 is amechanical element, a first state of the fill indicator 118 may indicateunder-inflation whereas the second state may indicate both optimalinflation and over-inflation.

In this figure, the pressure relief valve 120 and the fill indicator 118are situated in the second passage and the inflation port 116 is withinthe first passage to the retention balloon 108. In this exemplaryconfiguration, there is not an interaction between the second passagefrom the first passage other than the housing of the valve system body112, thus minimizing the footprint of user interaction with thesecomponents.

The fill indicator 118 shown in FIG. 1 comprises a dome positioned overthe second fluid passage. When the first pressure is reached, the domeexpands outward to provide a visual indication that the first pressurehas been reached. However, fill indicator 118 may alternatively oradditionally provide a pneumatic or electronic indication of when thefirst pressure is reached, for example, via a solenoid valve, pneumaticvalve, light emitting diode (LED) or other light, audible sound,wireless beeping, or the like.

The pressure relief valve 120 shown in FIG. 1 is an umbrella valvesituated on a valve seat 124. However, other pressure relief valvesuseful for a valve system provided herein are envisioned. As anon-limiting example, a valve system may comprise a spring loaded ballvalve, a spring loaded poppet valve, a rupturing disc, or a combinationthereof. Generally the pressure relief valve is selected to have acracking pressure (i.e. minimum pressure required to open the valve)within the valve system that corresponds to a maximum pressure of theretention balloon 108 to which it is connected.

The valve system B shown in FIG. 1 is useful for limiting the pressureof retention balloon 108 during inflation or when device A is maintainedwithin the body cavity of the patient. Methods of using valve system Bfor this purpose include: (a) providing an inflatable indwelling medicaldevice A as generally shown in FIG. 1, (b) inserting the retentionballoon 108 into the body cavity, and (c) introducing fluid into theretention balloon 108 via a source of fluid connected to inflation port116 of valve system B; wherein if a first pressure of the retentionballoon 108 is achieved, fill indicator 118 will provide an indicationof such pressure and excess fluid may with withdrawn through inflationport 116 until the pressure within the retention balloon 108 is reducedbelow the first pressure; and wherein if a second pressure of theretention balloon is achieved, the pressure relief valve 120 opens,releasing excess fluid from the retention balloon 108. For cases wherethe pressure relief valve can return to a non-open state (e.g., umbrellavalve, spring loaded ball valve, spring loaded poppet valve), when thepressure within retention balloon 108 is reduced below the secondpressure, the pressure relief valve returns to the non-open state.

In some embodiments, the inflation port 116 comprises a Luer fittingthat connects to a Luer lock syringe that serves as a source of fluid.In some cases, engagement of the source of inflation fluid to theinflation port 116 allows access of fluid to a Leur check valve, andwhen a certain pressure is met, allows for the opening of the Leur checkvalve. In some cases, engagement of the source of inflation fluid to theinflation port 116 opens a seal, allowing for access to a Leur checkvalve. The Luer check valve may comprise a body, stem and plug. In somecases, the stem comprises an elastic rubber. The Luer check valve may benormally closed such that when the stem of the valve is compressed bythe Luer tip of the source of inflation fluid (i.e., syringe), it opensup a fluid path to allow for passage of the fluid into the first passageof the valve system B.

An embodiment of a valve system B comprising an umbrella valve 132 as apressure relief valve is shown in FIG. 2A. As described in FIG. 1, valvesystem B comprises first and second passages enclosed within a body 112.For the valve system B shown in FIG. 2A, situated within the secondpassage is a fill indicator 118 and an umbrella valve 132 seated on avalve seat 134. A detailed view of umbrella valve 132 and valve seat 134is shown in FIG. 2B. Umbrella valve 132 comprises a sealing disk 136which flattens against the valve seat 134 with a certain sealing force,and a stem 138. The sealing disk 136 may have elastic materialproperties and convex shape to create the sealing force, while the stem138 is used to hold the umbrella valve 132 in place so as to avoid theneed for additional components such as a spring or positioner. The valveseat 134 comprises vents 140. When a force exerted on the sealing disk136 through vents 140 is sufficient to lift the convex diaphragm fromthe seat 134, the umbrella valve 132 allows for flow to occur in aforward direction (FIG. 2B, right panel), while preventing back flow inthe opposite direction (FIG. 2B, left panel). The umbrella valve 132 isorientated such that the forward direction is the direction that fluidtakes as it leaves the body 112 from the second passage, throughumbrella valve 132. Umbrella valve 132 may be selected such that theforce necessary to open the umbrella valve 132 corresponds to apredetermined pressure of retention balloon 108 that is conferred to thesecond passage of the valve system B. The predetermined pressure maycorrespond to the cracking pressure of the umbrella valve 132, which maybe from about 30 mm Hg to about 90 mm Hg, or from about 50 mm Hg toabout 70 mm Hg.

An embodiment of a valve system B is shown in FIG. 3A, comprising aspring loaded ball valve 142 that releases fluid when a predeterminedpressure is exceeded, and then closes when the pressure drops below thepredetermined level. A detailed view of the spring loaded ball valve isshown in FIG. 3B. The spring loaded ball valve 142 comprises a ball 144positioned against a spring 146, such that when the pressure of fluidwithin the balloon 108 exceeds a predetermined level, the fluid exerts aforce on the ball 144 that compresses spring 146 to allow the fluid tomove in a forward direction. A spring loaded ball valve 142 may beselected such that the force necessary to compress ball 144 correspondsto a predetermined pressure of balloon 108 that is recognized at thevalve system B. The predetermined pressure may correspond to thecracking pressure of the spring loaded ball valve 142, which may be fromabout 30 mm Hg to about 90 mm Hg, or from about 50 mm Hg to about 70 mmHg. In some embodiments, the cracking pressure is about 60 mm Hg.

An embodiment of a valve system B comprising a spring loaded poppetvalve 148 is shown in FIG. 4A. The spring loaded poppet valve 148 (FIG.4B) is positioned within the valve system B such that the spring of thepoppet valve 148 and the pressure from within the second passage applyopposing forces on the spring loaded poppet valve 148. When the forcefrom the second passage exerts a greater force than the spring force(i.e. the cracking pressure), then the poppet moves away from a valveseat, allowing fluid to pass through an outlet port of the spring loadedpoppet valve 148. As the pressure within the second passage drops belowthe cracking pressure of the valve, the valve closes.

Another type of pressure relief valve useful in a valve system Bprovided herein is a rupturing disc 150, as shown in FIG. 5. Therupturing disc comprises a one-time-use membrane 152 that ruptures at apredetermined differential pressure. In some cases, a valve systemprovided herein comprises a first pressure relief valve and as a backupdevice, a rupturing disc. For instance, if the pressure increases andthe first pressure relief valve fails to operate or does not relieveenough pressure fast enough, the rupturing disc will burst.

Valve Systems

In one aspect of the disclosure, valve systems provided herein have afirst and a second passage that are non-interfering or non-interacting.This is distinctively different from previously described valve systems,such as those described in U.S. 2015/0051542. For example, when thepressure of the present valve systems exceeds the pre-determined fillpressure, the first passage can continue to be filled in the presentdisclosure if the cracking pressure is set as such. Thus, the systemsherein allow for the cracking pressure to be set above thepre-determined filled pressure, while the valve system described in U.S.2015/0051542 would stop the flow from the first passage as soon as thepressure in the second passage reaches the pre-determined filledpressure. Such a design in the present disclosure has an advantage in aclinical use not achievable through the valve system in U.S.2015/0051542. Since the optimum fill pressure varies from patient topatient, valve systems with restricted flexibility of the operatingwindow allow the fill pressure to be varied due to patients. Forexample, the rectal pressure in an obese patient may be higher than therectal pressure of a patent with an average weight and rectum size. As aresult, the fill pressure in an obese patient population may need to beadjusted above the optimum fill pressure in order to allow the balloonto be inflated and thus anchored inside the rectum. With a proper choiceof the cracking pressure to be set above the optimum fill pressure, thepresent described systems allow for the balloon to be filled at apressure range above the optimum fill pressure. The optional fillindicator in the device offers a cue or signal to the proper fillvolume. At the same time, the cracking pressure of the pressure reliefvalve prevents the significant over-inflation that is harmful to thepatient. This is illustrated in FIG. 10, where there is a range of from40 ml to 50 ml filled volume to allow for balloon inflation when a60-mm-Hg pressure relief valve is used in one embodiment of the presentinvention. FIG. 10 also shows that in this embodiment, there is a rangeof from 40 ml to 60 ml filled volume to allow for balloon inflation whena 75-mm-Hg pressure relief valve is used. Such a wider operating rangeof the present systems allows a clinician to inflate rectal balloon inmost patients without the restrictions necessary using the systems ofU.S. 2015/0051542, where the operating range of the filled volume on aspecific patient was very narrow. The use of the optional fill indicatoradds another safety feature to allow clinician to judge the onset ofoptimum filled volume (thus balloon pressure).

Pressure Relief Valves

Provided herein are valve systems comprising a pressure relief valvehaving an open configuration and a closed configuration to permit ordeny, respectively, the passage of fluid to and/or from an inflatableportion of an inflatable indwelling medical device. As discussed, apressure relief valve is located within a second passage of the valvesystem so that any pressure spikes that may occur during inflation viathe first passage do not prematurely open the valve.

The pressure relief valve is selected in part to have a limited footprint in the valve system of an inflatable indwelling medical device. Asmall footprint minimizes the chance of developing a pressure sore whena patient lies over the valve system or rubs against it, such as may bethe case with a fecal catheter, Foley catheter and air way catheter,which are intimately close to sensitive areas of the body. In someembodiments, the height of a valve system comprising a pressure reliefvalve is less than or about 50 mm, 40 mm, 30 mm, 20 mm, 15 mm or 10 mm.In some embodiments, the height of a pressure relief valve is less thanor about 50 mm, 40 mm, 30 mm, 20 mm, 15 mm or 10 mm. In some cases, theheight of a valve system is less than about 20 mm. In some cases, theheight of a pressure relief valve is less than about 20 mm. In somecases, the height of a pressure relief valve is less than about 15 mm.In some cases, the height of a pressure relief valve is less than about10 mm.

The pressure relief valve is also selected for the cracking pressure, orthe minimum pressure within the second passage to force the valve open.The pressure relief valve may be selected so that its cracking pressurecorresponds to the pressure limitations required for the particularinflatable indwelling medical device. In some instances, the crackingpressure is met during inflation of the inflatable portion of thedevice. In some instances, the cracking pressure is met after ballooninflation, for example, the cracking pressure is achieved by pressurechanges within the inflatable portion which may be caused by pressurechanges within a patient's body, including pressure changes caused bycoughing, sneezing, peristalsis, movement, sitting, and crying.

In some embodiments, a cracking pressure of a valve in a systemdescribed herein is from about 10 mm Hg to about 120 mm Hg, about 10 mmHg to about 100 mm Hg, about 10 mm Hg to about 90 mm Hg, about 10 mm Hgto about 80 mm Hg, about 10 mm Hg to about 70 mm Hg, about 20 mm Hg toabout 90 mm Hg, about 20 mm Hg to about 80 mm Hg, about 30 mm Hg toabout 90 mm Hg, about 30 mm Hg to about 80 mm Hg, about 40 mm Hg toabout 90 mm Hg, about 40 mm Hg to about 80 mm Hg, about 50 mm Hg toabout 80 mm Hg, or about 50 mm Hg to about 70 mm Hg. The crackingpressure may be from about 50 mm Hg to about 70 mm Hg. In some cases,the cracking pressure of a valve is about within a system describedherein is about 30 mm Hg to about 90 mm Hg. The tolerance may be about±5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19% or20%. In some cases, the tolerance is about ±15%. The cracking pressuremay be from about 50 mm Hg to about 70 mm Hg with a tolerance of about±15%. In some cases, the cracking pressure of a valve is about 30, 35,40, 45, 50, 55, 60, 65, 70, 75, 80, 85 or 90 mm Hg with a tolerance of±10 mm Hg or preferably ±5 mm Hg. In various embodiments, a rate offluid flow within a lumen of a valve system is dependent on the crackingpressure of a valve of the system.

Pressure relief valves useful in the systems provided herein includeblow-off valves or cracking pressure check valves, wherein the valvesopen when a set pressure is reached. For example, once a predeterminedpressure is reached within a valve system, the valve opens to releasethe pressure, preventing over-inflation of an inflatable portion of aninflatable indwelling medical device. Non-limiting examples of pressurerelief valves useful in the valve systems described herein includeumbrella valves, duckbill valves, split valves, metal spring valves,film valves, and Belleville valves. In some embodiments, the valve isflanged. In other embodiments, the valve is sleeved. In someembodiments, the valve is a combination valve, for example, a valvecomprising two or more valves in one single component. In some cases, acombination valve comprises a duckbill and an umbrella.

The pressure relief valve may be a one-way valve that createsunidirectional flow in a device. In such instances, the pressure reliefvalve may comprise elastomeric sealing elements that allow forward flowand prevent backflow. Non-limiting examples of one-way valves include anumbrella valve, spring loaded ball valve, spring loaded poppet valve andrupturing disc. In some cases, the pressure relief valve is a two-wayvalve that allows for the passage of fluid in two directions when open.

Pressure relief valves may be made of any material suitable forintegration within an indwelling medical device. Materials include,without limitation, silicone, elastomers, fluoropolymers, synthetic ornatural rubbers, polyethylene, polypropylene, nylon, acetal, PVDF, ABS,and hydrocarbon-resistant fluorosilicone rubber. Elastomeric materialsare often characterized with a hardness of less than Shore A 75, lessthan Shore A 60, or preferably, less than Shore A 50. In someembodiments, a pressure relief valve is not ferromagnetic. In somecases, ferromagnetic valves are not used to allow a patient using avalve system within an indwelling medical device to be scanned bymagnetic resonance imaging.

In some embodiments, a pressure relief valve is mechanically held withina valve system, for example, the valve is positioned on a seat. In someembodiments, a pressure relief valve is glued or otherwise held within avalve system. In other embodiments, a pressure relief valve is welded toanother component of a valve system.

In some embodiments, a pressure relief valve is an umbrella valve. Inexemplary embodiments, the umbrella valve comprises a diaphragm shapedsealing disk, i.e., umbrella shape, and a stem. When mounted in a seat,the convex diaphragm flattens out against the valve seat and absorbs acertain amount of seat irregularities and creates a certain sealingforce. The umbrella valve will allow forward flow once the head pressurecreates enough force to lift the convex diaphragm from the seat and soit will allow flow at a predetermined pressure in one way and preventback flow immediately in the opposite way. In some embodiments, theopening pressure is variable by varying seat thickness. In some cases,the stem height is from about 1 mm to about 20 mm, or about 1, 2, 3, 4,5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20 mm. In somecases, the valve seat height is at least about 1, 2, 3, 4, or 5 mm. Insome cases, the sealing disk has a diameter from about 5 mm to about 20mm.

The cracking pressure of an umbrella valve may vary according to theconfiguration of the valve and/or the valve seat. In some embodiments,the height of a valve seat contributes to the cracking pressure of avalve residing in the seat. In some embodiments, the size of a vent inthe valve seat contributes to a cracking pressure of the valve. Forinstance, for a valve requiring a high flow rate, the flow vents in theseat are larger and for a valve requiring a low flow rate, the flowvents in the seat are smaller. In some cases, for a valve that requiresresistance to high backpressure, the flow vents in the seat are smaller,the seat is taller and the umbrella is more substantial such that theedge of the umbrella would be more difficult to lift up. In some cases,for a valve that requires resistance to low backpressure, the flow ventsin the seat are wider, the seat is thinner, and the umbrella is lesssubstantial such that the edge of the umbrella would be easier to liftup. In some embodiments, a valve seat is selected for a valve systemherein having a thickness of about 0.5 mm to about 5 mm, about 0.5 mm toabout 4 mm, about 0.5 mm to about 3 mm, about 0.5 mm to about 2 mm,about 0.5 mm to about 1 mm, about 1 mm to about 5 mm, about 1 mm toabout 4 mm, about 1 mm to about 3 mm, or about 1 mm to about 2 mm. Insome embodiments, a valve seat has a seat height of about 0.5, 0.6, 0.7,0.8, 0.9, 1, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2, or 2.5 mm.The cracking pressure of the umbrella valve may be from about 30 mm Hgto about 90 mm Hg, or from about 50 mm Hg to about 70 mm Hg.

In some embodiments, an umbrella valve is a Belleville valve comprisinga stem that is held in place in a seat by a retainer. This retainercould be a separate component or an integral part of the device in whichit is integrated such as a cap or lid just above the umbrella valve.

In some embodiments, a pressure relief valve is a duckbill valve. Inexemplary embodiments, the duckbill valve comprises elastomeric lips inthe shape of a duckbill which prevent backflow and allow forward flow.Duckbill valves may not require integration with a seat surface to forma seal. Instead, the sealing function of the valve is an integralcomponent of the valve.

In some embodiments, a pressure relief valve is a split valve. In someembodiments, a split valve comprises a distal slit partially across atransverse valve section, wherein the slit is configured to be open byreceipt of a force pushed against one side of the valve, and then closedwhen the force is removed. For example, the force is the pressureexerted by fluid within the valve system during inflation. As anotherexample, the force is the pressure within the valve system caused byapplication of another external force on an inflatable portion of aninflatable indwelling medical device. In some cases, the valve sealcomprises two opposing halves, either molded separately or formed froman integrally molded valve seal that is bisected and then fused togetherto form a weak bond that is easily broken during splitting.

In some embodiments, a pressure relief valve is a cartridge type inwhich a rigid seating is incorporated. In some cases, a cartridge typevalve typically comprises a body, O-ring, poppet, cartridge and a metalspring. In some cases, a cartridge type valve comprises a body, O-ring,and an umbrella valve. In some cases, a cartridge type valve comprises abody, O-ring, and a duckbill valve.

In some embodiments, a pressure relief valve is a film valve or crackingpressure check valve. In some embodiments, a pressure relief valve is anumbrella valve. A cracking pressure check valve comprises multiplecomponents that are integrated into a single, molded valve. By changingthe tension on the valve stem, a different cracking pressure can beachieved. The flow rate is controlled by varying the size of the valveorifices.

In some embodiments, a pressure relief valve is a spring loaded ballvalve that releases fluid when its cracking pressure is reached, andthen closes when the pressure drops below the cracking pressure. Thespring loaded ball valve may comprise a ball positioned against a springsuch that when the cracking pressure is reached, the pressure exerts aforce on the ball that compresses the spring to allow the fluid to movein a forward direction. The cracking pressure of the spring loaded ballvalve may be from about 30 mm Hg to about 90 mm Hg, or from about 50 mmHg to about 70 mm Hg.

In some embodiments, a pressure relief valve is a spring loaded poppetvalve positioned within the valve system such that the spring of thepoppet valve and the pressure from within the second passage applyopposing forces on the spring loaded poppet valve. When the force fromthe second passage exerts a greater force than the spring force (i.e.the cracking pressure), then the poppet moves away from a valve seat,allowing fluid to pass through an outlet port of the spring loadedpoppet valve. As the pressure within the second passage drops below thecracking pressure of the valve, the valve closes. The cracking pressureof the spring loaded poppet valve may be from about 30 mm Hg to about 90mm Hg, or from about 50 mm Hg to about 70 mm Hg.

Fill Indicator

In some embodiments, a valve system comprises, or is operably connectedto, a fill indicator that indicates to a clinician and/or user once aninflatable portion has reached and/or exceeded an optimal fill volume;an optimal fill pressure; or either an optimal fill volume or optimalfill pressure, whichever is reached first. The fill indicator may residewithin the body of the valve system or be a separate component from thebody. If the system comprises a return fluid path and an enclosure(e.g., return lumen), the fill indicator may reside within theenclosure. In some instances, the fill indicator resides within the bodyof a valve system in fluid communication with a return fluid path. Insome embodiments, a fill indicator is a visual and/or audible indicatorthat provides notification once an inflatable portion has reached orsurpassed an optimal fill volume and/or pressure. In some cases, a fillindicator is a mechanical element configured to alternate between afirst physical state and a second physical state depending on a pressurewithin the second passage corresponding to the pressure within theinflatable portion. As a non-limiting example, the mechanical element isin a first physical state when the optimal fill volume and/or pressurewithin the inflation portion has not been met, and in a second physicalstate when the optimal fill volume and/or pressure has been met orexceeded. In some cases, the mechanical element is in a first physicalstate when the inflatable portion is under-inflated. In some cases, themechanical element is in a second physical state when the inflatableportion is over-inflated. In various embodiments, the mechanical elementis in a second physical state when the inflatable portion is filled toan optimal fill volume and/or pressure.

In some embodiments, a valve system comprises both a fill indicator anda pressure relief valve, such that the fill indicator indicates when afirst pressure is achieved and the pressure relief valve preventsover-inflation when a second pressure is achieved. In some cases, thepressure relief valve prevents over-inflation by opening once the secondpressure is reached. In some cases, the second pressure is apredetermined fill pressure corresponding to the cracking pressure ofthe pressure relief valve. In some cases, the second pressure is amaximum fill pressure. In some cases, the first pressure is an optimalfill pressure. In some cases, the pressure relief valve preventsover-inflation by not allowing the inflatable portion to reach apressure higher than the first pressure. In some cases, the pressurerelief valve prevents over-inflation by not allowing the inflatableportion to reach a pressure higher than a desirable pressure, which ishigher than the optimal fill pressure, and is defined by the pressurethat could cause significant tissue damage over an extended period oftissue contact. In some cases, the pressure relief valve preventsover-inflation by not allowing the inflatable portion to reach apressure that is 5%, 10%, 15%, 20%, 25%, 30%, 50%, or 100% higher thanthe first pressure. In some cases, the first pressure is different fromthe second pressure. In some cases, the first pressure is lower than thesecond pressure. In some cases, the first and second pressures differ byless than about 100%, 75%, 50%, 40%, 30%, 20%, 15%, 10%, 5%, or 1%.

Inflatable Indwelling Medical Devices

The valves and valve systems provided herein are useful for controllingthe pressure within inflatable portions of indwelling medical devices.In some cases, the medical device comprises a rectal catheter. In somecases, the medical device comprises a urinary catheter. In some cases,the medical device comprises an airway catheter. In some cases, themedical device comprises a tracheal catheter. In some embodiments, theinflatable portion is a retention balloon configured to retain a distalend of device within a body cavity. In some cases, an inflatableportion, e.g., retention balloon, has a fill capacity less than about 70ml, 60 ml, 50 ml, 45 ml, 40 ml, 35 ml, 30 ml, 25 ml, 20 ml, 15 ml, 10 mlor less. In some cases, the inflatable portion is a retention balloon ofa fecal management system comprising a rectal catheter and has a fillcapacity from about 25 ml to about 60 ml, from about 25 ml to about 50ml, from about 35 ml to about 45 ml, from about 30 ml to about 60 ml,from about 30 ml to about 50 ml, from about 30 ml to about 45 ml, fromabout 35 ml to about 55 ml, from about 35 ml to about 50 ml, from about35 ml to about 45 ml, or from about 40 ml to about 50 ml. In some cases,the inflatable portion inflates with no more than about 55, 54, 53, 52,51, 50, 49, 48, 47, 46, 45, 44, 43, 42, 41 or 40 mL of liquid. In somecases, the inflatable portion inflates with no more than about 45 mL ofliquid. In such cases where the inflatable portion is inflated with nomore than 45 mL of liquid, the pressure within the inflatable portionmay be about 50 mm Hg±5 mm Hg when the pressure relief valve istriggered to open. In some cases, the inflatable portion inflates withno more than about 50 mL of liquid. In such cases where the inflatableportion is inflated with no more than 50 mL of liquid, the pressurewithin the inflatable portion may be about 50 mm Hg 5 mm Hg when thepressure relief valve is triggered to open. The pressure at which thepressure relief valve opens, the cracking pressure, may be tailored toeach patient. As such, the range of cracking pressures for a pressurerelief valve may be from about 50 mm Hg to about 70 mm Hg. This mayallow for variation between patients and pressure relief valves.

In some cases, the inflatable portion is a retention balloon of aurinary catheter that has a fill capacity from about 5 ml to about 20ml, from about 5 ml to about 15 ml, from about 8 ml to about 12 ml. Insome embodiments, the inflatable portion comprises a foam filling. Insome instances, the foam will self-inflate the inflatable portion. Thisenables the inflatable portion to return to its original size followinga pressure change. For example, the pressure changes with a contractionand expansion cycle within the body, such as occurs during and followinga cough. Suitable foams include polyurethane foams and memory foams.

In various aspects, a valve system described herein allows for aninflatable portion of an inflatable medical device to be filled withfluid to an optimal volume and/or pressure to prevent under-inflation orover-inflation of the inflatable portion. In some embodiments, the fluidis air. In some embodiments, the fluid is a liquid, for example, wateror saline solution.

In some embodiments, an optimal fill pressure is a pressure between aminimum pressure and a maximum pressure within an inflatable portion ofan inflatable indwelling medical device. In some cases, the minimumpressure corresponds to a minimum pressure necessary to retain theinflatable portion within a body cavity. In some cases, the maximumpressure is the highest amount of pressure an inflatable portion canhandle before the inflatable portion is over-inflated. Over-inflationmay result in abnormal blood perfusion in the soft tissue contacted bythe inflatable portion, and/or pressure necrosis of the soft tissue. Insome embodiments, an optimal fill pressure is from about 20 mm Hg toabout 90 mm Hg, from about 20 mm Hg to about 80 mm Hg, from about 20 mmHg to about 70 mm Hg, from about 20 mm Hg to about 60 mm Hg, from about20 mm Hg to about 50 mm Hg, from about 30 mm Hg to about 90 mm Hg, fromabout 30 mm Hg to about 80 mm Hg, from about 30 mm Hg to about 70 mm Hg,or from about 30 mm Hg to about 50 mm Hg. In some cases, a minimum fillpressure is from about 20 mm Hg to about 50 mm Hg, for example, about20, 25, 30, 35, 40, 45 or 50 mm Hg. In some cases, a maximum fillpressure is from about 40 to about 90 mm Hg, for example, about 40, 45,50, 55, 60, 65, 70, 75, 80, 85, or 90 mm Hg. In some embodiments, amaximum pressure corresponds to the cracking pressure of a valve usedwithin the system. In some embodiments, a maximum pressure correspondsto a pressure about 5%, 10%, 15%, 20%, 30%, 40%, or 50% greater than thecracking pressure of a valve used within the system. In someembodiments, a maximum pressure corresponds to the cracking pressure ofa valve used within the system. In some embodiments, a preferredoperation pressure corresponds to a pressure about 5%, 10%, 15%, 20%,30%, 40%, or 50% lower than the cracking pressure of a pressure reliefvalve used within the system.

In some embodiments, an optimal fill volume is a volume between aminimum fill volume and a maximum fill volume. In some cases, whereinthe valve system is part of an indwelling medical device, the minimumfill volume is the minimum volume of an inflatable portion necessary toretain the inflatable portion within a cavity of a patient. In somecases, the maximum fill volume is the maximum volume an inflatableportion can contain at a maximum pressure. In some cases, the optimalfill volume is patient dependent, for example, if the cavity of thepatient is small or is under pressure (e.g., in obese patients), theoptimal fill volume is lower than that of a patient with a larger cavityor a cavity that is not under said pressure. In some cases, the optimalfill volume for a retention balloon of an indwelling medical device isdependent on the characteristics of the body cavity, for example, theoptimal fill volume for a urinary catheter system is smaller than thatof a fecal catheter system. Non-limiting examples of minimum fillvolumes for inflatable portions of rectal catheter systems include 5 ml,10 ml, 20 ml, 25 ml, 26 ml, 27 ml, 28 ml, 29 ml, 30 ml, 31 ml, 32 ml, 33ml, 34 ml, 35 ml, 40 ml, 45 ml, 50 ml, and 60 ml. Non-limiting examplesof maximum fill volumes for inflatable portions of rectal cathetersystems include 25 ml, 30 ml, 35 ml, 36 ml, 37 ml, 38 ml, 39 ml, 40 ml,41 ml, 42 ml, 43 ml, 44 ml, 45 ml, 50 ml, 75 ml, and 100 ml. In someembodiments, an optimal fill volume for an inflatable portion of arectal catheter system comprising a valve system described herein isfrom about 20 ml to about 50 ml, from about 30 ml to about 50 ml, fromabout 35 ml to about 45 ml, from about 30 ml to about 45 ml, and fromabout 35 ml to about 45 ml.

In various aspects of the valve systems provided herein, a pressurerelief valve is configured to prevent over-inflation of an inflatableportion of an inflatable indwelling medical device past a predeterminedfill volume. In some cases, the predetermined fill volume is the maximumfill volume or about 100%, 75%, 50%, 30%, 25%, 20%, 15%, 10%, 5% or 1%less than the maximum fill volume. In other cases, the predeterminedfill volume is the optimal fill volume or about 5%, 10%, 15%, 20%, 25%,50%, 75% greater than the optimal fill volume. In some embodiments, avalve of a valve system prevents the over-inflation of the inflatableportion past a predetermined fill pressure. In some cases, thepredetermined fill pressure is the maximum fill pressure or about 100%,75%, 50%, 30%, 25%, 20%, 15%, 10%, 5% or 1% less than the maximum fillpressure. In other cases, the predetermined fill pressure is the optimalfill pressure or about 5%, 10%, 15%, 20%, 25%, 50%, 75% greater than theoptimal fill pressure. In some embodiments, a pressure relief valveprevents the inflation of the inflatable portion past either apredetermined fill volume or a predetermined fill pressure, whicheveroccurs first. As one example, the pressure relief valve prevents theover-inflation of the inflatable portion once it reaches a predeterminedfill pressure, even if the predetermined fill volume has not been met.This may occur in catheter devices, wherein the size of the body cavity(e.g., rectal cavity, bladder) is smaller or under more pressure in somepatients than in others.

In some cases, an indwelling medical device is a fecal catheter or aurinary catheter. Such a catheter comprises an inflation port, aballoon, a catheter tube, a drainable bag, a sample port, an irrigationport, etc. In some cases, the balloon is made from elastomers such as asilicone, natural rubber, or elastomers. In some cases, the catheter ismade from silicone, natural rubber, or elastomers. In some cases, theinflation port comprises a Luer access check valve to allow for ballooninflation. Balloon materials include, without limitation, plastic,silicone, elastomers, fluoropolymers, synthetic or natural rubbers,polyethylene, polypropylene, nylon, acetal, PVDF, ABS, andhydrocarbon-resistant fluorosilicone rubber.

An inflatable indwelling medical device may comprise: (a) an apparatuscomprising a fluid inlet port and a fluid outlet port connected by afirst passage, and a second passage, wherein the first passage and thesecond passage are not connected within the apparatus; (b) a retentionballoon; (c) a supply fluid path connecting the first passage of theapparatus at the fluid outlet port to the retention balloon; (d) areturn fluid path connecting the second passage to the retentionballoon; wherein the second passage comprises a pressure relief valvethat opens at a predetermined pressure. In some cases, the predeterminedpressure is from about 30 mm Hg to about 90 mm Hg, or from about 50 mmHg to about 70 mm Hg. In some cases, the inflatable indwelling medicaldevice further comprises a fill indicator that provides notificationwhen the retention balloon is filled to or above an optimal fill level.The fill indicator may be positioned at the second passage. Theretention balloon may be positioned at the distal end of a catheter forinsertion into a body cavity of a patient. The proximal end of thecatheter may be configured for coupling to a collection bag. In someembodiments, the inflatable indwelling medical device is a fecalmanagement system (FMS) and the catheter is a rectal catheter. In someembodiments, the inflatable indwelling medical device is a urinarymanagement system and the catheter is a urinary catheter. In someembodiments, the retention balloon is configured for insertion withinthe body cavity so that when the balloon is inflated to a minimum volumeand/or pressure, the inflated balloon maintains the distal end of thecatheter within the body cavity, allowing for body waste to flow fromthe body cavity, through the drain channel of the catheter, and into thecollection bag.

Methods of preventing over-inflation of a retention balloon of theindwelling medical device may comprise: (a) providing an indwellingmedical device comprising (i) a tubular element defining a drain passagefor effluent from a body cavity; (ii) a retention balloon located at adistal end of the tubular element for insertion into the body cavity;(iii) a housing comprising a pressure relief valve and an inflationport; (iv) an inflation lumen providing a first fluid path between theretention balloon and the housing, wherein the retention balloon islocated at a distal end of the inflation lumen and the inflation port islocated at a proximal end of the inflation lumen; and (v) a return lumenproviding a second fluid path between the retention balloon and thehousing, wherein the retention balloon is located at a distal end of thereturn lumen and the housing is located a proximal end of the returnlumen, and wherein the valve is in fluid communication with the secondfluid path; (b) inserting the retention balloon beyond an externalorifice and into a body cavity; (c) connecting an attachment membercomprising a fluid to the inflation port; (d) introducing the fluid intothe retention balloon from the attachment member at a flow rate that isless than a cracking pressure of the valve until the retention balloonreaches an optimal fill volume; (e) disconnecting the attachment member;and (f) maintaining the filled retention balloon within the cavity for adefined period of time; wherein a pressure within the retention balloonis regulated by the valve.

EXAMPLES Example 1

Fecal Management System Comprising a Valve System

A valve system is integrated within a fecal management system (FMS) toprevent over-inflation of the retention balloon of the FMS. The FMS hasthe configuration generally shown in FIG. 1. The FMS comprises aretention balloon 108 that is configured for placement within the rectalcavity to retain a catheter having a drain channel 102 for the diversionof waste fluids from the rectal cavity of a patient to a fluidcollection bag. The FMS of this example further comprises an auxiliarylumen to provide irrigation to the rectal cavity.

Over-inflation of the retention balloon 108 is achieved by utilizing avalve system generally depicted by “B” in FIG. 1. The valve system Bcomprises first passage connecting an inflation port 116 to an inflationlumen 110, which is further connected to the retention balloon 108. Theinflation port 116 comprises an opening to allow for the passage offluid between a syringe and the retention balloon 108 via a first fluidpathway comprising the first passage within the valve system B, and asupply fluid path within inflation lumen 110. The valve system B furthercomprises a second passage. A second fluid pathway connects theretention balloon 108, a return lumen 122, and the second passage. Inthis example, the second passage and the first passage do not interact.The second passage comprises a fill indicator that provides anotification, such as a visual notification, when an optimal pressurewithin the retention balloon 108 has been met. The second passagefurther comprises an umbrella valve having open and closedconfigurations. The umbrella valve opens when the pressure within thesystem reaches the cracking pressure of the valve, releasing pressurefrom within the system. The cracking pressure was selected to correspondto an over-inflation pressure within the retention balloon 108.

Example 2

Over-Inflation Control in a Fecal Management System Comprising a ValveSystem Equipped with a Pressure Relief Valve Set at 60 Mm Hg

Fill properties of retention balloons in a FMS as described in Example 1were compared to the properties of retention balloons in a FMS lacking apressure relief valves (control device).

A FMS as described in Example 1 was equipped with a pressure reliefvalve set at 60 mm Hg. A cartridge valve having an outside diameter of10 mm with a 7 mm umbrella valve made from a Shore A 50 silicone wasglued into the valve system. The height of the cartridge valve was 6 mm.The cartridge valve was made from ABS.

The retention balloons of the FMS with and without the pressure reliefvalves were filled with air from 5 cc up to 100 cc to observe theballoon diameter and the filled balloon pressure, respectively. The datawas plotted as shown in FIGS. 6-9.

As shown in FIG. 6, the balloon diameter expands linearly with thefilled volume in the control device lacking the pressure relief valve.In the systems comprising the pressure relief valve, the balloondiameter expands linearly with the filled volume until it reaches ataround 58.3 mm diameter, it then stays at around 58.3 mm upon furtherincrease in fill volume.

The measurement of the balloon pressure versus the filled volume withair is shown in FIG. 7. The balloon pressure stayed near zero initiallybecause the balloon was molded with a set diameter of around 51 mm. Theballoon pressure began to rise exponentially at around 35 ml filledvolume, and continued to rise to about 93 mm Hg in the control system.In the system comprising the pressure relief valve, the balloon pressurefollowed about the same trend as the control device at a filled volumefrom 0 ml to around 50 ml. After 50 ml, the balloon pressure stayed ataround 60 mm Hg because of the control by the pressure relief valve. Thesame test was repeated with the water instead of air. The plots of FIG.8 and FIG. 9 show that similar trends were observed as FIG. 6 and FIG.4, respectively.

These experiments show that the system comprising the pressure reliefvalve was effective in shutting off the pressure above the crackingpressure of the valve at 60 mm Hg, while allowing the system to befunctional above a 40 ml optimum filled volume, at which point the fillindicator dome would begin to indicate the onset of the ballooninflation.

Example 3

Over-Inflation Control in a Fecal Management System Comprising a ValveSystem Equipped With a Pressure Relief Valve Set at 75 Mm Hg

Fill properties of retention balloons in a FMS as described in Example 1were compared to the properties of retention balloons in FMS withoutpressure relief valves (control device).

A FMS as described in Example 1 was equipped with a pressure reliefvalve set at 60 mm Hg (as in Example 2), 75 mm Hg, or no pressure reliefvalve (control device). In the 75 mm Hg system, the cartridge valve hadan outside diameter of 10 mm with a 7 mm umbrella valve. The height ofthe cartridge was 6 mm. The cartridge valve was made from ABS. Thecartridge valve was glued into the valve system of the FMS of Example 1.

The balloons of each system were filled with water from 5 cc up to 100cc to observe the balloon pressure among three systems, respectively.The data was plotted as shown in FIG. 10. The balloon pressure stayednear zero initially since the balloon was molded with a set diameter ofaround 51 mm. The balloon pressure began to rise exponentially at around35 ml filled volume, and then continue to rise to about 93 mm Hg in thecontrol system. In the test system having the 60 mm Hg cracking pressurerelief valve, the balloon pressure followed about the same trend as thecontrol device at a filled volume from 0 ml to around 50 ml. After 50ml, the balloon pressure stayed at around 60 mm Hg. In the system havinga 75 mm Hg cracking pressure relief valve, the balloon pressure followedabout the same trend as the control device at a filled volume from 0 mlto around 60 ml. After 60 ml, the balloon pressure stayed at around 75mm Hg. This data show that the pressure relief valve systems wereeffective in shutting off the pressure above the cracking pressure ofthe valve (60 mm Hg or 75 mm Hg), while allowing the test device to befunctional above 40 ml optimum filled volume, in which the fillindicator dome would begin to indicate the onset of the ballooninflation.

Example 4

Over-Inflation Control in a Fecal Management System Comprising a SpringLoaded Ball Valve System Equipped with a Critical Pressure Relief Set at75 Mm Hg

An FMS as described in Example 1 was equipped with a spring loaded ballvalve having a critical relief pressure set at 75 mm Hg. The springloaded ball valve was purchased from Lee Co. (Westbrook, Conn., USA).The pressure relief valve has a diameter of 5.46 mm and a length of 7.3mm. The ball valve was built from ceramic with a stainless steelhousing, a stainless steel cage, and stainless steel spring. Thecritical relief pressure was controlled by the selection of the spring.The spring loaded ball valve was glued into the fill indicator of theFMS (Example 1), and is shown in FIGS. 3A and 3B.

The balloons of each system were filled with water from 5 cc up to 100cc to observe the balloon pressure. The data generated was similar tothe plot in FIG. 10 in that the pressure relief valve systems wereeffective in shutting off the pressure above the cracking pressure ofthe valve (75 mm Hg), while allowing the test device to be functionalabove 40 ml optimum filled volume, in which the fill indicator domewould begin to indicate the onset of the balloon inflation.

Example 5

Over-Inflation Control in a Fecal Management System Comprising a SpringLoaded Poppet Valve System Equipped With a Critical Pressure Relief Setat 75 Mm Hg

An FMS as described in Example 1 was equipped with a spring loadedpoppet valve having a critical relief pressure set at 75 mm Hg. Thespring loaded poppet valve was purchased from Check Valve, Inc.(Maplewood, Minn., USA). The pressure relief valve has a diameter of6.35 mm (¼″) and a length of 12.2 mm. The poppet valve was built fromnylon. The spring loaded poppet valve was glued into the fill indicatorof the FMS (Example 1), and is shown in FIGS. 4A and 4B.

The balloons of each system were filled with water from 5 cc up to 100cc to observe the balloon pressure. The data was similar to the plot inFIG. 10 in that the pressure relief valve systems were effective inshutting off the pressure above the cracking pressure of the valve (75mm Hg), while allowing the test device to be functional above 40 mloptimum filled volume, in which the fill indicator dome would begin toindicate the onset of the balloon inflation. Due to the height of poppetvalve, the profile of the mounted pressure relief valve is slightlyhigher than the spring loaded ball valve in Example 4.

While preferred embodiments of the present disclosure have been shownand described herein, it will be obvious to those skilled in the artthat such embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. It should be understoodthat various alternatives to the embodiments of the inventions describedherein may be employed in practicing the inventions. It is intended thatthe following claims define a scope of the inventions and that methodsand structures within the scope of these claims and their equivalents becovered thereby.

What is claimed is:
 1. An apparatus for limiting fluid pressure withinan inflatable portion of an inflatable device, wherein the inflatabledevice comprises a supply fluid path and a return fluid pathindividually connecting the inflatable portion to the apparatus, theapparatus comprising: a body comprising a fluid inlet port and a fluidoutlet port connected by a first passage, wherein the first passage isconnected to the supply fluid path at the fluid outlet port; a secondpassage connected to the return fluid path, wherein the first passageand the second passage are not in fluid communication within theapparatus; and a fill indicator in communication with the secondpassage, wherein the fill indicator is configured to provide anindication when fluid pressure in the second passage exceeds a firstpredetermined pressure; wherein a pressure relief valve is located suchthat when the fluid pressure in the inflatable portion and the secondpassage exceeds a second predetermined pressure, the pressure reliefvalve opens and excess fluid is released from the inflatable portion;and wherein the first predetermined pressure is less than the secondpredetermined pressure such that the apparatus is operable to inflatethe inflatable portion to pressures between the first predeterminedpressure and the second predetermined pressure.
 2. The apparatus ofclaim 1, wherein the first passage of the apparatus is not obstructedwhen the pressure within the inflatable portion exceeds the secondpredetermined pressure, such that the apparatus is configured to allowfor the inflatable portion to receive fluid via the first passage whenthe pressure within the inflatable portion exceeds the secondpredetermined pressure.
 3. The apparatus of claim 1, wherein the secondpredetermined pressure is the cracking pressure of the pressure reliefvalve.
 4. The apparatus of claim 1, wherein the second predeterminedpressure is from about 30 mm Hg to about 90 mm Hg, or from about 50 mmHg to about 70 mm Hg.
 5. The apparatus of claim 1, wherein the pressurerelief valve comprises an umbrella valve, spring loaded ball valve,spring loaded poppet valve, rupturing disk, or a combination thereof. 6.The apparatus of claim 1, wherein the pressure relief valve has a heightno greater than about 20, 15, 10, 9, 8, 7, 6 or 5 mm.
 7. The apparatusof claim 1, wherein the pressure relief valve is positioned within thesecond passage.
 8. The apparatus of claim 1, wherein the fill indicatoris a pressure indicator comprising a mechanical element configured toalternate between a first physical state and a second physical statewhen a pressure within the inflatable portion meets or exceeds anoptimal fill pressure.
 9. The apparatus of claim 8, wherein the optimalfill pressure is from about 10 mm Hg to about 60 mm Hg.
 10. A systemincluding the apparatus of claim 1, further comprising the inflatabledevice.
 11. The system of claim 10, wherein the inflatable portion has amaximum fill volume, at which point the pressure within the inflatableportion is the second predetermined pressure.
 12. The system of claim11, wherein the maximum fill volume is about 50 ml±5 ml.
 13. Theapparatus of claim 1, wherein the first predetermined pressurecorresponds to an optimal fill pressure for the inflatable portion. 14.The apparatus of claim 13, wherein the second predetermined pressure isbetween 5% higher than the first predetermined pressure and 100% higherthan the first predetermined pressure.
 15. The apparatus of claim 1,wherein the indication comprises a pneumatic indication.
 16. Theapparatus of claim 1, wherein the indication comprises an electronicindication.
 17. The apparatus of claim 16, wherein the electronicindication comprises a visible electronic indication.
 18. The apparatusof claim 16, wherein the electronic indication comprises an audibleelectronic indication.
 19. The apparatus of claim 1, wherein the firstpassage of the apparatus is not obstructed when the pressure within theinflatable portion exceeds the first predetermined pressure, such thatthe apparatus is configured to allow for the inflatable portion toreceive fluid via the first passage when the pressure within theinflatable portion exceeds the first predetermined pressure.
 20. Theapparatus of claim 1, wherein the second predetermined pressure is atleast 5% greater than the first predetermine pressure.
 21. The apparatusof claim 1, wherein the pressure relief valve is configured to permitthe fluid pressure in the second passage to exceed the firstpredetermined pressure.
 22. An apparatus for limiting fluid pressurewithin an inflatable portion of an inflatable device, wherein theinflatable device comprises a supply fluid path and a return fluid pathindividually connecting the inflatable portion to the apparatus, theapparatus comprising: a body comprising: a first passage comprising afluid inlet port and a fluid outlet port, wherein the fluid outlet portis configured for connection with the supply fluid path; and a secondpassage configured for connection with the return fluid path, whereinthe first passage and the second passage are not in fluid communicationwithin the apparatus; a fill indicator in communication with the secondpassage, wherein the fill indicator is configured to provide anindication when fluid pressure in the second passage exceeds a firstpredetermined pressure; and a pressure relief valve configured to openin response to fluid pressure within the second passage exceeding asecond predetermined pressure to thereby permit release of excess fluidfrom the inflatable portion; wherein the first predetermined pressure isless than the second predetermined pressure such that the apparatus iscapable of maintaining the fluid pressure in the second passage at alevel between the first predetermined pressure and the secondpredetermined pressure.
 23. The apparatus of claim 22, wherein the fillindicator comprises a pressure indicator including a mechanical elementconfigured to alternate between a first physical state and a secondphysical state when the fluid pressure in the second passage exceeds thefirst predetermined pressure; and wherein the first predeterminedpressure corresponds to an optimal fill pressure of the inflatableportion.
 24. The apparatus of claim 22, wherein the first passage of theapparatus is not obstructed when the pressure within the inflatableportion exceeds the first predetermined pressure, such that theapparatus is configured to allow for the inflatable portion to receivefluid via the first passage when the pressure within the inflatableportion exceeds the first predetermined pressure.
 25. The apparatus ofclaim 22, wherein the fill indicator is mounted to the body.
 26. Theapparatus of claim 22, wherein the first predetermined pressure is lessthan the second predetermined pressure.
 27. A system including theapparatus of claim 22, and further comprising the inflatable device;wherein the supply fluid path is connected with the first passage viathe fluid outlet port; and wherein the return fluid path is connectedwith the second passage.
 28. A method of using the system of claim 27,the method comprising: pressurizing a fluid such that fluid flows intothe inflatable portion via the first passage and the fluid supply path,and fluid flows into the second passage from the inflatable portion viathe return fluid path; in response to fluid pressure in the secondpassage exceeding the first predetermined pressure, providing theindication via the fill indicator.
 29. The method of claim 28, furthercomprising: in response to fluid pressure in the second passageexceeding the second predetermined pressure, opening the pressure reliefvalve to thereby permit release of excess fluid from the inflatableportion.
 30. The method of claim 29, wherein the first predeterminedpressure is less than the second predetermined pressure such that theindication is provided prior to opening of the pressure relief valve.31. A method, comprising: providing a system, the system comprising: aninflatable device comprising an inflatable portion, a supply fluid path,and a return fluid path individually connected with the inflatableportion; a body comprising: a first passage comprising a fluid inletport and a fluid outlet port, wherein the fluid outlet port is connectedwith the supply fluid path; and a second passage connected with thereturn fluid path, wherein the first passage and the second passage arenot in fluid communication within the body; a fill indicator incommunication with the second passage, wherein the fill indicator isconfigured to provide an indication when fluid pressure in the secondpassage exceeds a first predetermined pressure; and a pressure reliefvalve configured to open in response to fluid pressure within the secondpassage exceeding a second predetermined pressure to thereby permitrelease of excess fluid from the inflatable portion; wherein the firstpredetermined pressure is different from the second predeterminedpressure; pressurizing a fluid such that fluid flows into the inflatableportion via the first passage and the fluid supply path, and fluid flowsinto the second passage from the inflatable portion via the return fluidpath; in response to fluid pressure in the second passage exceeding thefirst predetermined pressure, providing the indication via the fillindicator; and in response to the indication, removing fluid from theinflatable portion via the first passage and the fluid supply path.